Low profile adaptor for use with a medical catheter

ABSTRACT

Low profile adaptor for use with a medical catheter, such as a gastrostomy feeding tube. In a preferred embodiment, the adaptor comprises a body having a lower portion and an upper portion. A first channel is provided in the lower portion, and a second channel is provided in the upper portion, the first and second channels being perpendicular to and in fluid communication with one another. A generally cylindrical stem is coaxially positioned within the second channel, the stem being rotatably mounted about its longitudinal axis. The stem is hollow and has an open front end, a closed rear end and a hole in its side wall, the hole being rotatably alignable with the first channel. To facilitate rotational alignment of the hole with the first channel, a stop is formed on the exterior of the stem, the stop being engageable with a surface positioned within the second channel. The front end of the stem is recessed relative to the front end of the second channel to prevent unwanted rotation of the stem. Rotation of the stem from a closed position to an open position is achieved by screwing a syringe onto the front end of the stem. The proximal end of the gastrostomy feeding tube is inserted over the lower portion of the body and is secured thereto with a nut.

BACKGROUND OF THE INVENTION

The present invention relates generally to medical catheters, such asgastrostomy feeding tubes, and relates more particularly to low profileadaptors well-suited for use with medical catheters.

Certain patients are unable to take food transorally due to an inabilityto swallow. Such an inability to swallow may be due to a variety ofreasons, such as esophageal cancer, neurological impairment and thelike. Although the intravenous administration of food to such patientsmay be a viable short-term approach, it is not well-suited for thelong-term. Accordingly, the most common approach to the long-termfeeding of such patients involves gastrostomy, i.e., the creation of afeeding tract or stoma between the stomach and the upper abdominal wall.Feeding is then typically performed by administering food through afeeding tube that has been inserted into the feeding tract, with thedistal end of the feeding tube extending into the stomach and beingretained therein by an internal anchor or bolster and the proximal endof the feeding tube extending through the abdominal wall.

Although gastrostomies were first performed surgically, mostgastrostomies are now performed using percutaneous endoscopy. In onetype of percutaneous endoscopic gastrostomy (PEG) technique, the distalend of an endoscope is inserted into a patient's mouth and is passedthrough the esophagus into the stomach. After distension of the stomachby inflation, an entry site on the abdomen is identified and an incisioncan be made. A needle, with an outer cannula, is inserted through theentry site across the abdominal and gastric walls. While keeping thecannula in place, the needle is then removed and a flexible wire ispassed through the cannula into the stomach. A snare loop is extendedfrom the distal end of the endoscope. The endoscopic snare loop is thenused to grasp the wire, the cannula is released, and the endoscope andwire are withdrawn through the esophagus and mouth of the patient. Asilicone gastrostomy feeding tube, the distal end of which is attachedto a silicone, dome-shaped internal bolster, is then secured to the wireand is pulled from its proximal end through the esophagus and into thestomach until the internal bolster engages the stomach wall and thefeeding tube extends through the stomach and abdominal walls, with theproximal end of the feeding tube extending approximately one foot beyondthe abdominal wall. (Over a period of several days followingimplantation of the feeding tube, a stable stoma tract forms around thefeeding tube between the gastric and abdominal walls.)

With the internal bolster in place against the gastric wall, an externalbolster is typically secured to the feeding tube to engage the abdomenso as to prevent longitudinal movement of the feeding tube within thestoma tract. Additionally, a “Y-port” adapter is typically attached tothe proximal end of the feeding tube, the Y-port adapter being adaptedto receive a pair of connector tips through which food and/ormedications may be dispensed. In addition, a detachable locking clip istypically secured to the feeding tube at a point between the externalbolster and the Y-port adapter to prevent gastric fluids from escapingthrough the proximal end of the feeding tube when the feeding tube isnot in use.

Alternative techniques for implanting gastrostomy feeding tubes usingpercutaneous endoscopic gastrostomy are disclosed in U.S. Pat. No.5,112,310, inventor Grobe, which issued May 12, 1992, and U.S. Pat. No.5,167,627, inventors Clegg et al., which issued Dec. 1, 1992, both ofwhich are incorporated herein by reference.

Although gastrostomy feeding tubes of the type described above work wellfor their intended purpose, many active patients find the nearly onefoot length of tubing that extends externally to be unwieldy, difficultto conceal and susceptible to being inadvertently pulled on. As canreadily be appreciated, these conditions are potential sources ofphysical and/or psychological trauma to the patient. Consequently, avariety of low-profile replacement tube assemblies (also referred to inthe art as low-profile replacement PEG devices) have been designed forimplantation within the stoma tract following the removal of aninitially-implanted gastrostomy feeding tube. Such replacementassemblies are referred to as being “low-profile” because they areconsiderably more compact externally than the above-describedinitially-implanted gastrostomy feeding tube assemblies.

An example of a low-profile replacement PEG device is disclosed in U.S.Pat. No. 4,944,732, inventor Russo, which issued Jul. 31, 1990, andwhich is incorporated herein by reference. The low-profile replacementPEG device of said patent comprises a deformable, conical tip portionhaving at least one side aperture therethrough, a tube portion whichextends rearwardly from the tip portion, a fitting portion on the rearend of the tube portion, a removable valve portion in the fittingportion and a flange portion which extends outwardly from the fittingportion. The device is adapted to be installed in a patient so that thetube portion extends through a pre-established stoma with the tipportion located in the patient's stomach and with the fitting portionand the flange portion engaging the skin of the patient adjacent thestoma.

The deformable tip portion of the above-described low-profilereplacement PEG device functions as an internal bolster to anchor itsassociated tube portion in a patient's stomach. To implant and/or removethe aforementioned tube portion from a patient's stomach, an obturatoror similar device is typically inserted through the tube portion and isused to elongate or otherwise deform the tip portion in such a way as topermit the tip portion to fit through the stoma. Removal of theobturator from the tip portion then permits the tip portion to expand toits original shape for anchoring.

Another type of low-profile replacement PEG device uses an inflatableballoon, instead of a deformable tip portion, as an internal bolster toretain the distal end of its associated tube within a patient's stomach.To implant such a device in a patient, the inflatable balloon isdeflated, the distal end of the tube portion is inserted through thestoma, and the balloon is then inflated. To remove the implanted devicefrom a patient, the balloon is deflated and the tube is then withdrawnfrom the stoma.

Further examples of low-profile replacement PEG devices are disclosed inU.S. Pat. No. 4,863,438, inventors Gauderer et al., which issued Sep. 5,1989; and U.S. Pat. No. 5,720,734, inventors Copenhaver et al., whichissued Feb. 24, 1998, both of which are incorporated herein byreference.

Although low-profile replacement PEG devices are less awkward and bulkythan initially-implanted gastrostomy tube assemblies, the use of suchlow-profile replacement PEG devices suffers from its own set ofshortcomings. One such shortcoming is that the implantation of alow-profile replacement PEG device must be preceded by the removal of aninitially-implanted gastrostomy tube. Such removal typically involvespulling on the proximal end of the gastrostomy tube until the internalbolster fails and is drawn through the stoma. As can readily beappreciated, such a procedure can be quite painful to the patient andcan result in damage to the stoma, thereby delaying when the replacementdevice can be implanted.

Another shortcoming of many low-profile replacement PEG devices is thatsuch devices typically do not last as long as initially-implantedgastrostomy tube assemblies (most commonly due to failure of theirinternal anchoring mechanisms or due to clogging or other failure oftheir valve mechanisms) and, therefore, must be replaced more frequentlythan is the case with initially-implanted gastrostomy tube assemblies.

Still another shortcoming of many low-profile replacement PEG devices isthat such devices are typically not adjustable in length. This can beproblematic because there is often an appreciable variation in stomalength from patient to patient. Consequently, it is typically necessary,after removal of the initially-implanted tube and prior to implantationof the replacement device, to measure the length of the stoma and thento select a replacement device having an appropriate length. As canreadily be appreciated, this approach requires that there be madeavailable an inventory of replacement devices of varying lengths.

In order to avoid the aforementioned shortcomings of low-profilereplacement PEG devices while, at the same time, avoiding theabove-described problems associated with having a gastrostomy tubeextend externally for a substantial length, there have recently beendevised a number of adaptors designed for use in converting aninitially-implanted gastrostomy tube into a low-profile PEG device. Onesuch adaptor is disclosed in U.S. Pat. No. 5,549,657, inventors Stern etal., which issued Aug. 27, 1996, and which is incorporated herein byreference. According to said patent, an adaptor is disclosed thereinthat is designed for use with a gastostomy feeding tube which has beeninserted by means of conventional endsocopic procedures and which hasbeen cut to a desired length by a surgeon. The adaptor is said tocomprise an anti-reflux valve assembly having a stem which can beplugged into the open end of the feeding tube. The valve assembly issaid to contain a seal which functions as a one-way valve to preventreflux of gastric contents but which permits the introduction of feedingsolution into the feeding tube. A clamp is placed around the feedingtube and the valve stem and is locked into place to secure the valveassembly to the feeding tube at a location flush with the patient'sskin. A silicone cover is placed around the clamp to protect the patientfrom skin irritation caused by the clamp and also to protect the clampand valve assembly from contaminants.

Although the aforementioned adaptor favorably addresses some of theproblems discussed above, the present inventors have identified certainshortcomings associated therewith. One such shortcoming is that thevalve assembly of the subject adaptor relies upon the use of a siliconegasket having a Y-shaped slot through which a cannula is typicallyinserted to deliver food and/or medications. However, such a siliconegasket, after repeated insertions of the cannula therethrough, has atendency to tear or to otherwise fail to act reliably as a one-wayvalve. Consequently, because the adaptor cannot easily be disconnectedfrom the gastrostomy feeding tube once connected thereto, replacement ofa worn adaptor requires the removal and replacement of the gastrostomytube as well.

Another shortcoming with the aforementioned adaptor is that it possessesa relatively small lumen through which fluid may pass. In addition, dueto its manner of operation, the valve tends to get clogged over time,further restricting fluid flow.

Still another shortcoming with the aforementioned adaptor is that theclamp of said adaptor has a tendency to pinch the proximal end of thegastrostomy tube at those points where the male and female sections ofthe clamp are joined. Such pinching, over time, has a tendency to causethe tube to tear.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a novel low profileadaptor designed for use with a medical catheter, such as a gastrostomyfeeding tube.

It is another object of the present invention to provide a low profileadaptor as described above which, when used with a gastrostomy feedingtube, overcomes at least some of the shortcomings discussed herein inconnection with PEG devices, in general, and low profile PEG adaptors,in particular.

Therefore, according to one aspect of the invention, there is providedan adaptor well-suited for use with a medical catheter, such as agastrostomy feeding tube, said adaptor comprising (a) a lumen, saidlumen being adapted for fluid communication with the medical catheter;and (b) a tube, said tube being adapted for fluid communication with anexternal conduit, said tube being rotatable about its longitudinal axisbetween an open position in which said tube is in fluid communicationwith said lumen and a closed position in which said tube is not in fluidcommunication with said lumen.

According to another aspect of the invention, there is provided anadaptor well-suited for use with a medical catheter, such as gastrostomyfeeding tube, said adaptor comprising (a) a body, said body beingprovided with a first channel and a second channel, said first channeland said second channel being in fluid communication with one another,said first channel being adapted for fluid communication with a medicalcatheter; and (b) a stem, said stem having a front end, a rear end, aside wall, a cavity extending rearwardly from said front end, and a holein said side wall in fluid communication with said cavity, said stembeing mounted within said second channel of said body and beingrotatable between an open position in which said stem and said firstchannel are in fluid communication with one another via said hole and aclosed position in which said stem and said first channel are not influid communication with one another.

In a preferred embodiment, the adaptor comprises a body having a lowerportion and an upper portion. A first channel is provided in the lowerportion, and a second channel is provided in the upper portion, thefirst and second channels being perpendicular to and in fluidcommunication with one another. A generally cylindrical stem iscoaxially positioned within the second channel, the stem being rotatablymounted about its longitudinal axis. The stem is hollow and has an openfront end, a closed rear end and a hole in its side wall, the hole beingrotatably alignable with the first channel. To facilitate rotationalalignment of the hole with the first channel, a stop is formed on theexterior of the stem, the stop being engageable with a surfacepositioned within the second channel. The front end of the stem isrecessed relative to the front end of the second channel to preventunwanted rotation of the stem. An external thread is formed on the frontend of the stem. Rotation of the stem from a closed position to an openposition is achieved by screwing onto the front end of the stem aninternally threaded member that matingly engages the external thread onthe front end of the stem. The proximal end of the gastrostomy feedingtube is inserted over the lower portion of the body and is securedthereto with a nut.

As can readily be appreciated, although the adaptors discussed above aredescribed as being low profile adaptors, such adaptors are also suitablefor use with medical catheters, such as gastrostomy feeding tubes, thatextend externally for several inches. Accordingly, the adaptors of thepresent invention are not limited to being low profile adaptors.

The present invention is also directed to a PEG device comprising agastrostomy feeding tube having a proximal end and a distal end, aninternal bolster secured to the distal end of the gastrostomy feedingtube, and an adaptor of the type described above secured to the proximalend of the gastrostomy feeding tube.

For purposes of the present specification and claims, relational termslike “top,” “bottom,” “upper,” and “lower” are used to describe thepresent invention in a context in which the invention is secured to acatheter extending upwardly out of a patient. It is to be understoodthat, by orienting a patient such that the catheter extends outwardly ina direction other than upwardly, the corresponding description of thedirectionality of the invention will need to be adjusted accordingly.

Additional objects, features, aspects and advantages of the presentinvention will be set forth, in part, in the description which followsand, in part, will be obvious from the description or may be learned bypractice of the invention. In the description, reference is made to theaccompanying drawings which form a part thereof and in which is shown byway of illustration specific embodiments for practicing the invention.These embodiments will be described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is to be understoodthat other embodiments may be utilized and that structural changes maybe made without departing from the scope of the invention. The followingdetailed description is, therefore, not to be taken in a limiting sense,and the scope of the present invention is best defined by the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are hereby incorporated into andconstitute a part of this specification, illustrate preferredembodiments of the invention and, together with the description, serveto explain the principles of the invention. In the drawings wherein likereference numerals represent like parts:

FIG. 1 is an exploded section view of a first embodiment of a lowprofile adaptor constructed according to the teachings of the presentinvention for use with a gastrostomy feeding tube;

FIG. 2 is a partially exploded section view of the low profile adaptorof FIG. 1, said low profile adaptor being shown in its open positionwith a gastrostomy feeding tube inserted over a portion of the adaptorbody;

FIGS. 3( a) and 3(b) are fragmentary front section views of the lowprofile adaptor of FIG. 2 taken along line 1—1, said low profile adaptorbeing shown in its open and closed positions, respectively;

FIGS. 4( a) and 4(b) are top views, broken away in part, of the lowprofile adaptor of FIG. 1, said low profile adaptor being shown in itsopen and closed positions, respectively;

FIG. 5 is a section view of the low profile adaptor of FIG. 1, said lowprofile adaptor being shown in its closed position with a gastrostomyfeeding tube securely connected thereto;

FIG. 6 is a side view of the stem shown in FIG. 1;

FIG. 7 is a side view, broken away in part, of a conventional syringesuitable for use with the adaptor of FIG. 1;

FIG. 8 is a top view, broken away in part, of a second embodiment of alow profile adaptor constructed according to the teachings of thepresent invention for use with a gastrostomy feeding tube, said lowprofile adaptor being shown in its open position;

FIG. 9 is a section view of the low profile adaptor of FIG. 8, said lowprofile adaptor being shown in its closed position;

FIG. 10 is a top view, broken away in part, of a third embodiment of alow profile adaptor constructed according to the teachings of thepresent invention for use with a gastrostomy feeding tube, said lowprofile adaptor being shown in its open position;

FIG. 11 is a section view of the low profile adaptor of FIG. 8, said lowprofile adaptor being shown in its open position;

FIG. 12 is a perspective view of a fourth embodiment of a low profileadaptor constructed according to the teachings of the present inventionfor use with a gastrostomy feeding tube;

FIG. 13 is a top view, broken away in part, of a fifth embodiment of alow profile adaptor constructed according to the teachings of thepresent invention, said low profile adaptor being shown in its openposition;

FIG. 14 a partially exploded section of the low profile adaptor of FIG.13, said low profile adaptor being shown in its open position with agastrostomy feeding tube inserted over a portion of the adaptor body;

FIG. 15 is a side view, broken away in part, of a tube assembly suitablefor use with the adaptor of FIG. 13; and

FIG. 16 is a perspective view of the connector shown in FIG. 15.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to FIGS. 1 through 5, there are shown various views of afirst embodiment of a low profile adaptor constructed according to theteachings of the present invention for use with a medical catheter, suchas a gastrostomy feeding tube, said low profile adaptor beingrepresented generally by reference numeral 11.

Adaptor 11 comprises a body 13. Body 13, which is preferably made ofmolded medical grade plastic, is a unitary member shaped to include alower portion 15 and an upper portion 17, lower portion 15 extendinggenerally vertically and upper portion 17 extending generallyhorizontally and being positioned over lower portion 15.

Lower portion 15, which is generally cylindrical, is shaped to define atube support 19 and a pair of steps 21 and 23 of increasing outerdiameter at the top end of support 19. (Although two steps 21 and 23 areshown in the present embodiment, it can readily be appreciated thatgreater than or less than two steps could be formed at the top end ofsupport 19.) A lumen 25 having a circular cross-section extendslongitudinally through support 19 and steps 21 and 23 and continues fora short distance into upper portion 17 for reasons to become apparentbelow. As seen best in FIGS. 2 and 5, tube support 19 and step 21 areappropriately dimensioned so that a gastrostomy feeding tube GT may beinserted thereover. Also for reasons to become apparent below, step 23is provided with external threads 27.

Upper portion 17, which, when viewed from above, has an hourglass shapeto facilitate its being grasped with the thumb and forefinger of anoperator, is provided with a channel that extends rearwardly from thefront end 33 of upper portion 17 to a point prior to the rear end 35 ofupper portion 17, said channel being shaped to include a front portion37, an intermediate portion 39 and a rear portion 41. Front portion 37is rectangular in transverse cross-section and is centered within frontend 33 of upper portion 17 so that a rectangular shield 43 is formedbounding front portion 37 on all four sides thereof. Intermediateportion 39, which is smaller in overall transverse cross-sectional areathan front portion 37, is equidistantly spaced between the left andright sides 43-1 and 43-2, respectively, of shield 43 and is shaped todefine a left side 45, a right side 47, a bottom and an open top, saidopen top extending through the top 51 of upper portion 17 and serving asa window 53 for reasons to become apparent below. Said bottom ofintermediate portion 39 is shaped to include a semi-circular groove 49flanked on opposite sides by stop surfaces 55 and 57, the functions ofgroove 49 and stop surfaces 55 and 57 also to become apparent below.Rear portion 41 of the channel of upper portion 17 is generallycylindrical in shape, the bottom half of rear portion 41 being alignedwith and sized to match groove 49. A groove 59 of increased transversecross-sectional area is formed within rear portion 41 proximate to thefront end thereof, the function of groove 59 to be discussed below. Rearportion 41 is in fluid communication with lumen 25 for reasons to becomeapparent below, with the rear end 61 of rear portion 41 extending justbeyond lumen 25.

Adaptor 11 also comprises an elongated tube or stem 71 (shown separatelyin FIG. 6), stem 71 being rotatably mounted about its longitudinal axiswithin the aforementioned channel of upper portion 17. Stem 71, which ispreferably made of molded medical grade plastic, is a generallycylindrical unitary member shaped to include a front end 73, a rear end75 and a side wall 77. Stem 71 is sized so that front end 73 is spacedrearwardly relative to front end 33 of upper portion 17, with rear end75 flush against rear end 61 of upper portion 17. Front end 73 is shapedto define a radially outwardly extending collar. Threads 79 are formedon the exterior perimeter of front end 73 for reasons to become apparentbelow. A channel is formed in stem 71, said channel comprising a frontportion 81 and a rear portion 83. Front portion 81 extends rearwardlyfrom front end 73 a short distance and is inwardly tapered from frontend 73 to matingly receive a medical luer. Rear portion 83, which isgenerally cylindrical in shape, extends rearwardly from front portion 81to a point just before rear end 75. A hole 85 is formed in side wall 77for accessing rear portion 83, hole 85 being alignable, depending uponthe rotational position of stem 71, with lumen 25. A stop block 87 isformed on the outside surface of side wall 77 for engaging stop surfaces55 and 57, thereby delimiting the rotation of stem 71. An annular snapseal 89 is formed on the outside surface of side wall 77, snap seal 89fitting into groove 59 so to keep stem 71 in place longitudinally withinupper portion 17.

Adaptor 11 further comprises a ring-shaped member or nut 91, nut 91serving as an external bolster for a gastrostomy feeding tube and beingused to secure the gastrostomy feeding tube to body 13. Nut 91, which ispreferably made of molded medical grade plastic, is a generally annularunitary member comprising a top surface 93, a bottom surface 95, anouter surface 97 and a central bore. The central bore is shaped toinclude a lower portion 99, an intermediate portion 101 and an upperportion 103. Lower portion 99 is appropriately dimensioned to securelyreceive tube support 19 and a gastrostomy feeding tube GT insertedthereover. Intermediate portion 101 is appropriately dimensioned tosecurely receive step 21 and the proximal end of the gastrostomy feedingtube GT. Upper portion 103 is appropriately dimensioned to securelyreceive step 23, upper portion 103 being provided with internal threads105 for mating with external threads 27 of step 23.

To convert a high profile gastrostomy feeding assembly to a low profileassembly using adaptor 11, a gastrostomy feeding tube is implanted in apatient by a physician in the manner described above so that the distalend of the tube is positioned in the patient's stomach and retainedtherein using an internal bolster, with the proximal end of the tubeextending externally for a distance of several inches. The physician (orother medical care giver) then cuts the implanted gastrostomy feedingtube to a desired length. Nut 91 is then inserted over the proximal endof the gastrostomy feeding tube and is moved distally across thegastrostomy feeding tube until it is positioned against the patient'sskin. With stem 71 preferably switched to its closed position withinbody 13, the physician then inserts the proximal end of the gastrostomyfeeding tube GT up over tube support 19 and across step 21. Body 13 andthe attached gastrostomy feeding tube are then lowered into nut 91, andstep 23 is screwed into upper portion 103 of nut 91. Attachment ofadaptor 11 to the gastrostomy feeding tube is now complete. As can beseen in FIG. 5, adaptor 11, in its closed state, serves to preventreflux of gastric fluids conveyed by gastrostomy feeding tube GT.

To deliver food and/or medications to a patient via adaptor 11, one mayuse a conventional syringe or tube of the type having at one end amedical luer surrounded by an internally threaded sleeve. An example ofsuch a syringe is shown in FIG. 7, which depicts a syringe 111 having afront end shaped to include a medical luer 113 surrounded by a sleeve115, sleeve 115 being provided with an internal thread 117. In use, luer113 is inserted into front portion 81 of the channel of stem 71, andsleeve 115 is rotated clockwise. Initial rotation of sleeve 115 causesthreads 117 to engage threads 79 of stem 71 and results in the rotationof stem 71 from its closed position wherein stop block 87 is positionedon top of stop surface 57 and hole 85 is turned approximately 180degrees away from lumen 25 to its open position wherein stop block 87 ispositioned on top of stop surface 55 and hole is aligned with lumen 25.(Stop block 87 is visible through window 53, and printed indicators ontop 51 of upper portion 17 proximate to window 53 may be used to assistan operator in identifying whether stop block 87 is in an open or closedposition.) Continued rotation of sleeve 115 will tighten the engagementof sleeve 115 to stem 71 but will not result in further rotation of stem71 due to stop surface 55. With adaptor 11 now in its open position,food and/or medications may be dispensed from syringe 111 throughadaptor 11. When the dispensing of food and/or medications is complete,sleeve 115 is rotated counterclockwise, causing stop block 87 to bemoved from its open position on top of stop surface 55 to its closedposition engaged with stop surface 57. Continued rotation of sleeve 115will disengage sleeve 115 and luer 113 from stem 71, without furtherrotation of stem 71 due to stop surface 57.

As can be appreciated, one advantage of adaptor 11, as compared toexisting valve-type adaptors of the type described above, is that itslumen size, in the open position, is not restricted. Another advantageis that adaptor 11 cannot easily be moved from a closed position to anopen position, unless a device like syringe 111 is attached thereto.Still another advantage is that a device like syringe 111 cannot easilybe pulled out of adaptor 11 when adaptor 11 is in its open position.Still yet another advantage is that adaptor 11, when in its openposition, is connected to the delivery system in such a way as toprevent leakage of the fluids being administered to the patient and,when in its closed position, does not permit bodily fluids from thepatient to escape therethrough.

As can also readily be appreciated, instead of being attached to agastrostomy feeding tube, low-profile adaptor 11 could alternatively beattached to the proximal end of a jejunostomy feeding tube or could beused as a low-profile replacement enteral feeding device. Furthermore,in addition to being used for feeding, adaptor 11 could also be used forfluid drainage, for example, by being attached to a urine or blooddrainage catheter.

As can further be appreciated, although body 13 is constructed in thepresent embodiment so that lumen 25 and the channel formed in upperportion 17 are perpendicular, one could adjust the angle therebetween,for example, enlarging the angle therebetween to facilitate alignment ofa syringe with stem 71.

Referring now to FIGS. 8 and 9, there are shown top and section views ofa second embodiment of a low profile adaptor constructed according tothe teachings of the present invention for use with a medical catheter,such as a gastrostomy feeding tube, said low profile adaptor beingrepresented generally by reference numeral 151.

Adaptor 151 is similar in most respects to adaptor 11, one differencebetween the two adaptors being that adaptor 151 comprises an upperportion 153 that, when viewed from above, is oval-shaped, as opposed tobeing hourglass-shaped. Another difference is that the front end 155 ofupper portion 153 is shaped to shield stem 71 from the top and bottom,but not from the sides. Still another difference is that adaptor 151comprises a nut 157 whose outer surface 159 includes a beveled region161.

Referring now to FIGS. 10 and 11, there are shown top and section viewsof a third embodiment of a low profile adaptor constructed according tothe teachings of the present invention for use with a medical catheter,such as a gastrostomy feeding tube, said low profile adaptor beingrepresented generally by reference numeral 201.

Adaptor 201 is similar in most respects to adaptor 11, one differencebetween the two adaptors being that adaptor 201 comprises an upperportion 203 that, when viewed from above, is generally rectangular withrounded ends, as opposed to being hourglass-shaped. Another differenceis that adaptor 201 comprises a nut 205 having an outwardly extendingflange 207. Still another difference is that adaptor 201 comprises astem 209 having an open rear end 211.

Referring now to FIG. 12, there is shown a perspective view of a fourthembodiment of a low profile adaptor constructed according to theteachings of the present invention for use with a gastrostomy feedingtube, said low profile adaptor being represented generally by referencenumeral 251.

Adaptor 251 is similar in many respects to adaptor 11, one differencebetween the two adaptors being that adaptor 251 has an upper portion 253that is generally cylindrical in shape, as opposed to beinghourglass-shaped. Another difference is that adaptor 251 does notinclude a nut that serves as an external bolster. Instead, adaptor 251has a lower portion 255 that is shaped to include an outwardly extendingcircumferential flange 257, flange 257 serving as an external bolster.Still another difference is that the bottom of lower portion 255 isshaped to include a circumferential ridge 259, ridge 259 beingappropriately dimensioned so that the proximal end of a gastrostomyfeeding tube may be inserted over ridge 259 and secured thereto by somesecuring mechanism, such as a ratchet-type clamp (not shown). In anotherembodiment (not shown), the bottom of lower portion 255 could simply bebarb-shaped, with no additional mechanism being used to secure agastrostomy feeding tube thereto.

Referring now to FIGS. 13 and 14, there are shown top and section views,respectively, of a fifth embodiment of a low profile adaptor constructedaccording to the teachings of the present invention for use with agastrostomy feeding tube, said low profile adaptor being representedgenerally by reference numeral 301.

Adaptor 301 is similar in many respects to adaptor 11, one differencebetween the two adaptors being that, whereas adaptor 11 has a body 13that is hourglass-shaped when viewed from above, adaptor 301 has a body303 that, when viewed from above, includes a generally rectangular frontportion 305 and a generally circular rear portion 307.

Another difference between the two adaptors is that the interior channelof front portion 305 is provided with a circular groove 309, the purposeof which will be discussed below.

Still another difference between the two adaptors is that adaptor 301includes a nut 311, nut 311 being identical to nut 91, except that nut311 is provided with a cylindrical cavity 313 extending radiallyinwardly from its outer surface 315 to a point prior to its inner bore.Adaptor 301 further includes a rod 317, rod 317 being insertable intocavity 313 to facilitate the tightening of nut 311 around a gastrostomyfeeding tube and body 303.

Still yet another difference between the two adaptors is that adaptor301 includes a stem 321, stem 321 being identical to stem 71, exceptthat stem 321 has a front end 323 shaped to define a semi-annulartongue, instead of front end 73, which is provided with threads. Frontend 323 is set back relative to front 306 of front portion 305.

Referring now to FIG. 15, there is shown a side view, broken away inpart, of a tube assembly suitable for use with adaptor 301, said tubeassembly being represented generally by reference numeral 351.

Assembly 351 includes a delivery tube 353 for use in conveying foodand/or medications to a patient, delivery tube 353 having a proximal end355 and a distal end 357. Assembly 351 also includes a hollow connector361 (shown separately in FIG. 16), connector 361 having a proximal end363 and a distal end 365. Proximal end 363 is inserted into distal end357 of tube 353 and is retained therein by glue or a friction fit.Distal end 365 of connector 361 is shaped to define a semi-annulartongue dimensioned complemetarily to front end 323 of stem 321 so thatdistal end 365 of connector 361 can be fitted together with front end323 of stem 321 and, thereafter, can be used to rotate stem 321. AnO-ring 371 is securely mounted over connector 361, O-ring 371 beingpositioned on connector 361 so as to be received in groove 309 whenconnector 361 and stem 321 are fitted together. In this manner,engagement of connector 361 against stem 321 may be maintained.

As can readily be appreciated, the particular shapes of distal end 365of connector 361 and front end 323 of stem 321 in the present embodimentare illustrative only; other mating or otherwise engageable arrangementsfor connector 361 and stem 321 could also be used.

As can also readily be appreciated, in addition to being used toadminister food and/or medications to a patient, assembly 351 couldalternatively be used for draining fluids from a patient.

The embodiments of the present invention recited herein are intended tobe merely exemplary and those skilled in the art will be able to makenumerous variations and modifications to it without departing from thespirit of the present invention. All such variations and modificationsare intended to be within the scope of the present invention as definedby the claims appended hereto.

1. An adaptor well-suited for use with a medical catheter, said adaptorcomprising: (a) a body, said body being provided with a first channeland a second channel, said first channel and said second channel beingin fluid communication with one another, said first channel beingadapted for fluid communication with the medical catheter, said secondchannel having a front end; and (b) a stem, said stem having a front, arear, a side wall, a cavity extending rearwardly from said front end,and a hole in said side wall in fluid communication with said cavity,said stem being mounted within said second channel of said body withsaid front end of said stem being spaced rearwardly from said front endof said second channel, said stem being rotatable between an openposition in which said stem and said first channel are in fluidcommunication with one another via said hole and a closed position inwhich said stem and said first channel are not in fluid communicationwith one another.
 2. The adaptor as claimed in claim 1 wherein said bodyis shaped to include an upper portion and a lower portion, said upperportion being disposed on top of said lower portion.
 3. The adaptor asclaimed in claim 2 wherein said lower portion is generally cylindricaland is shaped to include a tube support, said tube support beinginsertable into the proximal end of the medical catheter, said tubesupport surrounding at least a portion of said first channel.
 4. Theadaptor as claimed in claim 3 wherein said second channel is disposedwithin said upper portion, said second channel being accessible from thefront of said upper portion.
 5. The adaptor as claimed in claim 4wherein said first channel and said second channel are generallyperpendicular to one another.
 6. The adaptor as claimed in claim 3further comprising means for securing the medical catheter to said lowerportion.
 7. The adaptor as claimed in claim 6 wherein said securingmeans comprises a ring-shaped member, said ring-shaped member beinginsertable over the medical catheter and said lower portion.
 8. Theadaptor as claimed in claim 7 wherein said ring-shaped member isprovided with a recess extending radially inwardly from its outersurface, said adaptor further comprising a rod insertable into saidrecess.
 9. The adaptor as claimed in claim 3 wherein said lower portionis further shaped to include at least one step of increasing outerdiameter on top of said tube support.
 10. The adaptor as claimed inclaim 3 wherein said lower portion is further shaped to include lowerand upper steps of increasing outer diameter on top of said tubesupport, said lower step being insertable into the proximal end of themedical catheter, said upper step being externally threaded.
 11. Theadaptor as claimed in claim 10 further comprising a nut insertable overthe proximal end of the medical catheter and engageable with said upperstep for securing the medical catheter to said lower portion, said nuthaving a bore complementarily shaped to said upper step, said lower stepand at least a portion of said tube support.
 12. The adaptor as claimedin claim 3 wherein said lower portion is shaped to include a tubesupport surrounding at least a portion of said first channel, said tubesupport being insertable into the proximal end of the medical catheterand having a barb at its bottom end.
 13. The adaptor as claimed in claim2 wherein said upper portion has a top surface, said top surface beinghourglass-shaped.
 14. The adaptor as claimed in claim 1 wherein lessthan the entirety of the periphery of said front end of said stem isshielded by said body.
 15. The adaptor as claimed in claim 1 wherein theentire periphery of said front end of said stem is shielded by saidbody.
 16. The adaptor as claimed in claim 1 wherein said front end ofsaid stem is externally threaded to engage a complementarily threadedsleeve.
 17. The adaptor as claimed in claim 16 wherein said front end ofsaid stem is externally threaded to engage a complemetarily threadedsleeve surrounding a medical luer, said medical luer being insertableinto said cavity of said stem.
 18. The adaptor as claimed in claim 1wherein said cavity of said stem is shaped to receive a medical luer.19. The adaptor as claimed in claim 1 wherein the exterior of said sidewall of said stem is shaped to include a stop block and wherein saidsecond channel is shaped to include a pair of stop surfaces, said stopblock being engageable with said stop surfaces in such a way as to limitthe range of rotation of said stem between said open and closedpositions.
 20. The adaptor as claimed in claim 19 wherein said body isprovided with a window to permit viewing of said stop block in said openand closed positions.
 21. The adaptor as claimed in claim 20 whereinindicators are disposed on said body proximate to said window forcorrelating the position of said stop block with said open and closedpositions.
 22. The adaptor as claimed in claim 1 wherein the exterior ofsaid side wall of said stem is shaped to include a snap seal and whereinsaid second channel is shaped to include a groove, said groove beingshaped to receive said snap seal so as to keep said stem in placelongitudinally within said second channel.
 23. The adaptor as claimed inclaim 1 wherein said rear of said stem is closed.
 24. The adaptor asclaimed in claim 1 wherein said rear of said stem is open.
 25. Thecombination of an adaptor as claimed in claim 1 and a tube assembly,said tube assembly comprising a tube and a connector, said connectorbeing hollow and having a proximal end and a distal end, said proximalend being coupled to said tube for fluid communication therewith, saiddistal end being matingly engageable with said front end of said stemfor fluid communication therewith.
 26. The combination as claimed inclaim 25 wherein said distal end of said connector is shaped to define asemi-annular tongue, and wherein said front end of said stem is shapedto define a complementary semi-annular tongue.
 27. The combination asclaimed in claim 25 wherein said tube assembly further comprises anO-ring secured around said connector and wherein said second channel isshaped to include a groove, said groove being dimensioned to receivesaid O-ring to maintain engagement of said stem and said connector. 28.The combination of an adaptor as claimed in claim 1 and a syringe, saidsyringe having an inner cannula and an internally threaded outer sleeveat its distal end, said front end of said stem being externally threadedto engage said internally threaded outer sleeve and wherein said cavityof said stem is shaped to receive said inner cannula.
 29. Thecombination as claimed in claim 28 wherein said inner cannula is amedical luer.
 30. A PEG device comprising a gastrostomy feeding tubehaving a proximal end and a distal end, an internal bolster secured tothe distal end of the gastrostomy feeding tube, and an adaptor asclaimed in claim 1 secured to the proximal end of the gastrostomyfeeding tube.
 31. The combination of an adaptor as claimed in claim 1and a drainage catheter, said drainage catheter being coupled to saidbody so as to be in fluid communication with said first channel.